MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ATS3000 ITALIAN; TOURNIQUET, PNEUMATIC

Catalog Number 60300030105

Device Problem Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the device does not work properly, due to spontaneous deflation, loss of pressure.Event occurred before surgery and there was no patient involvement.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event was recorded by zimmer biomet under (b)(4).The device history record for ats 3000 tourniquet system serial number (b)(6) was reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The record reviews found no issues with the device and all verifications, inspections, and tests were successfully completed.Using the machine-repair reports and the repair sites folders on livelink to query for all repairs on serial number (b)(6) prior to 10 may 2019, the device was noted to have not been previously repaired.The reported event was confirmed by the service technician who performed the evaluation and repair.On 10 may 2019, it was reported that the tourniquet system did not work due to spontaneous deflation and that it lost pressure.The customer returned an a.T.S.3000 tourniquet system, serial number (b)(6), for evaluation.Evaluation of the device on 3 june 2019 and noted that the footpads were missing, the lcd screen was damaged, that there were corroded screws, a broken pole clamp cover and a corroded knob.Upon further inspection, it was found that the tourniquet system issued a valve failure upon boot up and that the control board and the lop sensor were defective.Repair of the tourniquet system occurred on 7 august 2019 and involved replacing the footpads, lcd display, pole clamp knob and cover, multiple screws, the lop sensor and the control board as well as recalibrating the device.The technician then tested and verified that the device was functioning as intended.The tourniquet system was then returned to the customer without further incident.The device was tested, inspected, and repaired.While the service technician found that the device was issuing a valve failure upon boot up of the device and found that the failure was resolved after replacing the control board, it cannot be determined from the information provided how the control board failed such that it would cause the valves to malfunction.Therefore, a specific root cause of the reported event cannot be determined.Review of the information provided during the investigation determined that there are no further actions needed at this time.This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

No additional event information.

• Brand Name: ATS3000 ITALIAN
• Type of Device: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8646974
• MDR Text Key: 146267987
• Report Number: 0001526350-2019-00414
• Device Sequence Number: 1
• Product Code: KCY
• Combination Product (y/n): N
• PMA/PMN Number: K050411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60300030105
• Device Lot Number: 60484836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1